Mannitol and sorbitol are hexitols used together in a sterile, nonpyrogenic, hypotonic aqueous solution for urologic nonelectrolytic and nonhemolytic irrigation during transurethral prostatic resection and other transurethral surgical procedures. Mannitol; sorbitol was originally approved for use by the FDA in February 1980.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Other Administration Route(s)
-Visually inspect parenteral products for particulate matter and discoloration prior to administration, whenever the solution and container permit. Do not administer unless the irrigating agent is clear, the seal is intact, and the container is undamaged.
-Mannitol; sorbitol irrigation should be administered only by transurethral instillation with appropriate urologic instrumentation. A disposable administration set should be used.
-The contents of an opened container should be used promptly, to minimize the possibility of bacterial growth or pyrogen formation.
-Discard the unused portion.
-Height of the container(s) above the operating table in excess of 60 cm (approximately 2 ft) has been reported to increase intravascular absorption of the irrigating fluid.
Mannitol; sorbitol is solely intended for urologic irrigation use. It should not be administered via any other route. Adverse reactions may result from intravascular absorption of this product. The literature reports occasional adverse reactions from intravenous mannitol; sorbitol infusions. Should any adverse reaction(s) occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if it is deemed necessary.
Consequences of mannitol; sorbitol irrigating solution absorption include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, mouth dryness (xerostomia), thirst (polydipsia), and dehydration.
Consequences of mannitol; sorbitol irrigating solution absorption include cardiovascular disorders such as hypotension, tachycardia (e.g., sinus tachycardia), and chest pain (unspecified), similar to those of angina.
Consequences of mannitol; sorbitol irrigating solution absorption include pulmonary disorders such as pulmonary congestion (e.g., pulmonary edema).
Consequences of mannitol; sorbitol irrigating solution absorption include blurred vision.
Consequences of mannitol; sorbitol irrigating solution absorption include back pain, chills, diarrhea, nausea, and vomiting.
Consequences of irrigating solution absorption include rhinitis and urticaria. Allergic reactions from mannitol; sorbitol use, have also been reported.
Consequences of mannitol; sorbitol irrigating solution absorption include seizures and vertigo.
Mannitol; sorbitol is contraindicated for use in patients with anuria. Solutions for urologic irrigation must be used with caution in patients with severe renal impairment or renal failure. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter systemic circulation in relatively large volumes. Absorption of large amounts of fluids containing mannitol; sorbitol and the osmotic diuresis it produces may significantly alter renal dynamics. Following systemic absorption of this solution, sodium-free intracellular fluid shift into the extracellular compartment may lower serum sodium concentration and aggravate pre-existing hyponatremia. Excessive water and electrolyte loss may lead to serious electrolyte imbalance and dehydration. With continuous irrigation, water loss may occur in excess of electrolytes, producing hypernatremia. Sustained diuresis that results from transurethral irrigation with mannitol; sorbitol solution may obscure and intensify inadequate hydration. This product should not be given by any dosage route, including parenteral administration, beyond urologic irrigation.
Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary dysfunction (e.g., cardiac disease, pulmonary disease). Cardiovascular status, especially in patients with cardiac disease, should be carefully observed before and during prostatic transurethral resection when using mannitol; sorbitol solution. This is because the quantity of fluid absorbed into systemic circulation by opened prostatic veins may produce significant extracellular fluid expansion, leading to fulminating congestive heart failure. Sustained diuresis that results from transurethral irrigation with this product may obscure and intensify hypovolemia.
Hyperglycemia from sorbitol metabolism may occur in patients with diabetes mellitus. Hyperlactatemia from sorbitol metabolism may potentially produce a significant lactic acidosis in metabolically compromised (e.g., hepatic disease) patients. Mannitol; sorbitol irrigation solution should not be used in patients unable to metabolize sorbitol rapidly enough to avoid the development of hyperosmolar states, such as hyperosmolar hyperglycemic state (HHS).
Mannitol; sorbitol irrigation is classified as FDA pregnancy risk category C. Animal reproduction studies have not been conducted with this product. It is also unknown if the solution can cross the placenta and cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Mannitol; sorbitol should be given to a pregnant woman only if clearly needed, when the potential benefits to the mother outweigh the potential risks to the fetus.
According to the manufacturer, caution should be exercised when mannitol; sorbitol irrigation is administered to a nursing woman, since it is unknown if the solution is excreted in breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For urologic irrigation during transurethral prostatic resection and other transurethral surgery procedures:
Transurethral instillation dosage:
Adults: Administer via transurethral instillation; the total volume of solution administered is determined by the surgeon. NOTE: Height of the container(s) above the operating table in excess of 60 cm (approximately 2 ft) has been reported to increase intravascular absorption of the irrigating fluid.
Maximum Dosage Limits:
-Adults
Maximum dosage information is not available.
-Geriatric
Maximum dosage information is not available.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are required.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are required.
*non-FDA-approved indication
There are no drug interactions associated with Mannitol; Sorbitol products.
Mannitol and sorbitol are both nonelectrolytic hexitols. A solution of these constituents in water is nonconductive and suitable for urologic irrigation during electrosurgical procedures. About a 3% concentration of mannitol; sorbitol contains sufficient solute to minimize the risk of intravascular hemolysis, which can occur from plain water absorption through open prostatic veins during transurethral resection (TUR). Any solution that is absorbed intravascularly during transurethral prostatic or bladder surgery, although variable in amount and depending primarily on the surgical extent, will be renally excreted. When absorbed intravascularly, mannitol and sorbitol act as osmotic diuretics. Intravascular absorption has been shown to produce elevations of serum lactate after TUR above preoperative values, owing to sorbitol's favored metabolism to lactate from pyruvate. Increased lactate levels were not sufficient to produce evidence of metabolic acidosis.
Mannitol; sorbitol is administered via urologic irrigation. Any solution that is absorbed intravascularly during transurethral prostatic or bladder surgery, although variable in amount and depending primarily on the surgical extent, will be renally excreted.